A new study reveals that no difference in cure rates exists between vaginal prolapse repair with and without use of mesh. This, after three years of follow-up.
The research evaluated cure rates for 65 women—anatomic, symptomatic, and combined—who were randomized to traditional vaginal prolapse surgery in which mesh is not utilized and vaginal colpopexy in which repair is accomplished with mesh, according to HealthDay News; 33 women received mesh and 32 women did not. Participants were included if they completed three-year validated quality-of-life questionnaires and two- or three-year post-operative blinded Pelvic Organ Prolapse (POP) Quantification examinations. Women who needed re-operation for recurrent POP were excluded from anatomic and subjective outcomes analysis, HealthDay News added. Robert E. Gutman, MD, from Georgetown University in Washington, DC, and peers conducted the study; study results appear in the September 6th online version of Obstetrics & Gynecology.
The study was halted early by the researchers due to a mesh exposure rate of 15.6 percent. By the three-year follow-up, three women had died; three women were forced to undergo additional surgeries for recurrent POP, in the mesh group; and eight women were lost to follow-up, according to HealthDay News. No differences were seen in prolapse state or individual prolapse points between both groups at three years. No significant stage improvement was seen and there were no differences in symptomatic improvement scores, HealthDay News reported.
“There was no difference in three-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh,” the authors wrote, according to HealthDay News.
Thousands of women were recipients of transvaginal mesh devices, which have come under intense scrutiny as many women who were implanted with these devices are reporting complications allegedly related to their defects. Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and POP, conditions most commonly caused by weakened pelvic muscles. The devices are meant to help correct these conditions by providing additional strength to the pelvic walls.
Vaginal mesh devices received FDA clearance through the 510(k) expedited process under which formal safety and efficacy reviews are neither required nor performed. The FDA has stated that complications linked to transvaginal mesh implants are “not rare,” warning that use of these devices may actually be more harmful when compared to alternative methods for treating POP. The agency also recently reported that the most common complications associated with these devices may include:
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Organ perforation
- Urinary problems